Utak Laboratories Inc

FDA Filings

This page includes the latest FDA filings for Utak Laboratories Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number2022375
FEI Number2022375
NameUTAK LABORATORIES, INC.
Owner & OperatorUTAK LABORATORIES, I
Contact Address25020 AVENUE TIBBITTS --
Valencia CA 91355 US
Official Correspondent
  • Kevin M Kopp
  • x-661-2943935-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address25020 AVENUE TIBBITTS
VALENCIA, CA 91355 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
UTAK LABORATORIES, INC.
SELENIUM 200 UG/L SELEN 200 S BP2024-05-15
UTAK LABORATORIES, INC.
SELENIUM 100 UG/L SELEN 100 S BP2024-05-15
UTAK LABORATORIES, INC.
CERTIFIED DRUG FREE URINE 88121-CDF(F)10 FS 2024-05-14
UTAK LABORATORIES, INC.
7-AMINOCLONAZEPAM LOW 7-AMINO LOW UPM2024-05-13
UTAK LABORATORIES, INC.
7-AMINOCLONAZEPAM HIGH 7-AMINO HIGH UPM2024-05-13
UTAK LABORATORIES, INC.
LAMOTRIGINE PLUS LEVEL 3 LAMO+ 3 V3 S UCH2024-05-10
UTAK LABORATORIES, INC.
LAMOTRIGINE PLUS LEVEL 2 LAMO+ 2 V3 S UCH2024-05-10
UTAK LABORATORIES, INC.
LAMOTRIGINE PLUS LEVEL 1 LAMO+ 1 V3 S UCH2024-05-10
UTAK LABORATORIES, INC.
THC CONTROL 3 THC QC 3 U F WDH2024-05-09
UTAK LABORATORIES, INC.
THC CONTROL 2 THC QC 2 U F WDH2024-05-09
UTAK LABORATORIES, INC.
THC CONTROL 1 THC QC 1 U F WDH2024-05-09
UTAK LABORATORIES, INC.
THC CONTROL 0 THC QC 0 U F WDH2024-05-09
UTAK LABORATORIES, INC.
THC LEVEL 8 THC 8 U F WDH2024-05-09
UTAK LABORATORIES, INC.
THC LEVEL 7 THC 7 U F WDH2024-05-09
UTAK LABORATORIES, INC.
THC LEVEL 6 THC 6 U F WDH2024-05-09
UTAK LABORATORIES, INC.
THC LEVEL 5 THC 5 U F WDH2024-05-09
UTAK LABORATORIES, INC.
THC LEVEL 4 THC 4 U F WDH2024-05-09
UTAK LABORATORIES, INC.
THC LEVEL 3 THC 3 U F WDH2024-05-09
UTAK LABORATORIES, INC.
THC LEVEL 2 THC 2 U F WDH2024-05-09
UTAK LABORATORIES, INC.
THC LEVEL 1 THC 1 U F WDH2024-05-09
UTAK LABORATORIES, INC.
THC LEVEL 12 THC 12 U F WDH2024-05-09
UTAK LABORATORIES, INC.
THC LEVEL 11 THC 11 U F WDH2024-05-09
UTAK LABORATORIES, INC.
THC LEVEL 10 THC 10 U F WDH2024-05-09
UTAK LABORATORIES, INC.
THC LEVEL 0 THC 0 U F WDH2024-05-09
UTAK LABORATORIES, INC.
TESTOSTERONE PLUS LEVEL 2 TESTO+ 2 WB MTL2024-05-09
UTAK LABORATORIES, INC.
LEFLUNOMIDE HIGH LEVEL 3 LEFLU HIGH L3 V22024-05-08
UTAK LABORATORIES, INC.
LEFLUNOMIDE HIGH LEVEL 2 LEFLU HIGH L2 V22024-05-08
UTAK LABORATORIES, INC.
LEFLUNOMIDE HIGH LEVEL 1 LEFLU HIGH L1 V22024-05-08
UTAK LABORATORIES, INC.
CARBAMAZEPINE-10,11-EPOXIDE LEVEL 3 C1011 L3 V42024-05-08
UTAK LABORATORIES, INC.
CARBAMAZEPINE-10,11-EPOXIDE LEVEL 2 C1011 L2 V42024-05-08
UTAK LABORATORIES, INC.
CARBAMAZEPINE-10,11-EPOXIDE LEVEL 1 C1011 L1 V42024-05-08
UTAK LABORATORIES, INC.
CERTIFIED DRUG FREE URINE 100ML 88121-CDF(F)100 PDH2024-05-08
UTAK LABORATORIES, INC.
NICOTINE PLUS 1200 NG/ML V2 NICO+ 1200 V2 U F UWHC2024-05-07
UTAK LABORATORIES, INC.
NICOTINE PLUS 100 NG/ML V2 NICO+ 100 V2 U F UWHC2024-05-07
UTAK LABORATORIES, INC.
HYDROXYPROGESTERONE LEVEL 2 HPROG 2 S F FUMC2024-05-07
UTAK LABORATORIES, INC.
HYDROXYPROGESTERONE LEVEL 1 HPROG 1 S F FUMC2024-05-07
UTAK LABORATORIES, INC.
VALIDITY CHECK LOW VAL CHECK L CLH2024-05-06
UTAK LABORATORIES, INC.
ETHANOL 80 1ML ETH WB QC 80 V DOJ-1 2024-05-06
UTAK LABORATORIES, INC.
TRAMADOL POS POS-225-2U2024-05-03
UTAK LABORATORIES, INC.
CCDKMQC2V2WBUK CCDKM QC 2 V2 WB UK2024-05-03
UTAK LABORATORIES, INC.
CCDKM QC LEVEL 1 V2 CCDKM QC 1 V2 WB UK2024-05-03
UTAK LABORATORIES, INC.
ETHANOL 300 MG/DL ETH 300F WB LCCL2024-05-02
UTAK LABORATORIES, INC.
CLINICAL LOW V4 CLIN L V4 F BPC2024-05-02
UTAK LABORATORIES, INC.
CLINICAL HIGH V4 CLIN H V4 F BPC2024-05-02
UTAK LABORATORIES, INC.
VOLATILES LEVEL 2 VOL 2 V2 S F RIH 2024-05-01
UTAK LABORATORIES, INC.
VOLATILES LEVEL 1 VOL 1 V2 S F RIH2024-05-01
UTAK LABORATORIES, INC.
BENZODIAZEPINES PLUS 150 NG/ML BENZO+ 150 VA2024-05-01
UTAK LABORATORIES, INC.
URIC ACID NEGATIVE URIC ACID NEG S F BD2024-04-29
UTAK LABORATORIES, INC.
POSITIVE POS S F BD2024-04-29
UTAK LABORATORIES, INC.
METALS LOW METALS LOW S F EBS2024-04-26
UTAK LABORATORIES, INC.
METALS HIGH METALS HIGH S F EBS2024-04-26
UTAK LABORATORIES, INC.
PSYCH PANEL LEVEL 2 PSYCH 2 F M ACL2024-04-24
UTAK LABORATORIES, INC.
PSYCH PANEL LEVEL 1 PSYCH 1 F M ACL2024-04-24
UTAK LABORATORIES, INC.
DRUGS OF ABUSE POSITIVE DAU POS V2 U F PHHC2024-04-24
UTAK LABORATORIES, INC.
DRUGS OF ABUSE NEGATIVE SCREEN V2 DAU NEG V2 U F PHHC2024-04-24
UTAK LABORATORIES, INC.
CALIBRATOR VS 3 CAL VS 3 F M ACL2024-04-24
UTAK LABORATORIES, INC.
CERTIFIED DRUG FREE URINE 88121-CDF(L)500 SCP2024-04-24
UTAK LABORATORIES, INC.
SMX VITREOUS HUMOR SMX-VH(150) MCM2024-04-18
UTAK LABORATORIES, INC.
QC LEVEL 3 V3 QC V3 C-3 U F AP2024-04-17
UTAK LABORATORIES, INC.
QC LEVEL 2 V3 QC V3 C-2 U F AP2024-04-17
UTAK LABORATORIES, INC.
QC LEVEL 1 V3 QC V3 C-1 U F AP2024-04-17
UTAK LABORATORIES, INC.
GHB 40 UG/ML GHB 40 U NJSP 2024-04-17
UTAK LABORATORIES, INC.
GHB 2 UG/ML GHB 2 WB NJSP2024-04-17
UTAK LABORATORIES, INC.
GHB 25 UG/M GHB 25 U NJSP 2024-04-17
UTAK LABORATORIES, INC.
GHB 20 UG/ML GHB 20 WB NJSP2024-04-17
UTAK LABORATORIES, INC.
GHB 10 UG/ML GHB 10 WB NJSP2024-04-17
UTAK LABORATORIES, INC.
GHB 10 UG/ML GHB 10 U NJSP2024-04-17
UTAK LABORATORIES, INC.
BUTALBITAL PLUS 3 V2 BUTALBITAL+ 3 V2 AP2024-04-17
UTAK LABORATORIES, INC.
BUTALBITAL PLUS 2 V2 BUTALBITAL+ 2 V2 AP2024-04-17
UTAK LABORATORIES, INC.
BUTALBITAL PLUS 1 V2 BUTALBITAL+ 1 V2 AP2024-04-17
UTAK LABORATORIES, INC.
VOLATILES LEVEL 2 UTAK-WBC VOL 2 SD2024-04-16
UTAK LABORATORIES, INC.
VOLATILES LEVEL 1 UTAK-WBC VOL 1 SD2024-04-16
UTAK LABORATORIES, INC.
PETH LEVEL 2 PETH 2 WB F UCSD2024-04-11
UTAK LABORATORIES, INC.
METHYLMALONIC ACID PLUS LEVEL 2 MMA+ 2 S F UCSD2024-04-11
UTAK LABORATORIES, INC.
METHYLMALONIC ACID PLUS LEVEL 1 MMA+ 1 S F UCSD2024-04-11
UTAK LABORATORIES, INC.
NORMAL RANGE TRACE ELEMENTS V3 66816 V3 NR LC2024-04-11
UTAK LABORATORIES, INC.
HIGH RANGE TRACE ELEMENTS V3 66815 V3 HR LC2024-04-11
UTAK LABORATORIES, INC.
DRUGS OF ABUSE POSITIVE DA POS V2 WB F KBI 2024-04-10
UTAK LABORATORIES, INC.
CODEINE GLUCURONIDE PLUS LEVEL 1 COD GLUC+ 1 U PM2024-04-05
UTAK LABORATORIES, INC.
DRUGS OF ABUSE LEVEL 2 DAU 2 F HCMC2024-04-03
UTAK LABORATORIES, INC.
DRUGS OF ABUSE LEVEL 1 DAU 1 F HCMC2024-04-03
UTAK LABORATORIES, INC.
BUPRENORPHINE PLUS LEVEL 2 BUP+ 2 U F FML2024-04-03
UTAK LABORATORIES, INC.
BUPRENORPHINE PLUS LEVEL 1 BUP+ 1 U F FML2024-04-03
UTAK LABORATORIES, INC.
PENTOBARBITAL LEVEL 2 PENTO 2 S NCH2024-04-02
UTAK LABORATORIES, INC.
PENTOBARBITAL LEVEL 1 PENTO 1 S NCH2024-04-02
UTAK LABORATORIES, INC.
LEAD LEVEL 3 LEAD 3 WB F BCH2024-04-02
UTAK LABORATORIES, INC.
LEAD LEVEL 2 LEAD 2 WB F BCH2024-04-02
UTAK LABORATORIES, INC.
LEAD LEVEL 1 LEAD 1 WB F BCH2024-04-02
UTAK LABORATORIES, INC.
VITAMINS LEVEL 1 VIT L1 S MAYO2024-04-01
UTAK LABORATORIES, INC.
EIA STANDARD V3 EIA STD V3 WB DOJ2024-04-01
UTAK LABORATORIES, INC.
EIA C2 V3 EIA C2 V3 U F DOJ2024-04-01
UTAK LABORATORIES, INC.
EIA C1 V3 EIA C1 V3 WB DOJ2024-04-01
UTAK LABORATORIES, INC.
DRUGS OF ABUSE LOW DAU L NIH2024-04-01
UTAK LABORATORIES, INC.
DRUGS OF ABUSE HIGH DAU H NIH 2024-04-01
UTAK LABORATORIES, INC.
BUSULFAN CALIBRATOR LEVEL 6 V2 BUS CAL 6 V2 DP F MDACC2024-04-01
UTAK LABORATORIES, INC.
BUSULFAN CALIBRATOR LEVEL 5 V2 BUS CAL 5 V2 DP F MDACC2024-04-01
UTAK LABORATORIES, INC.
BUSULFAN CALIBRATOR LEVEL 4 V2 BUS CAL 4 V2 DP F MDACC2024-04-01
UTAK LABORATORIES, INC.
BUSULFAN CALIBRATOR LEVEL 3 V2 BUS CAL 3 V2 DP F MDACC2024-04-01
UTAK LABORATORIES, INC.
BUSULFAN CALIBRATOR LEVEL 2 V2 BUS CAL 2 V2 DP F MDACC2024-04-01
UTAK LABORATORIES, INC.
BUSULFAN CALIBRATOR LEVEL 1 V2 BUS CAL 1 V2 DP F MDACC2024-04-01
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
TRICYLIC ANTIDEPRESSANTS Vi2016-10-19
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
TRICYLIC ANTIDEPRESSANTS Li Tx Control2016-10-19
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Whole Blood Lead Controls2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
UTAK Toxicology Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Trace Elements Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Clonazepam Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
UTAK STABBS Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Vancomycin Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Benzodiazepines Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Flurazepam Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Disopyramide Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Pentobarbital Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Caffeine Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Tricyclic Antidepressants Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Maprotiline Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Amoxapine Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
UTAK Toxicology Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Tricyclic Antidepressants Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Hypnotics + Salicylate Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Hypnotics + Acetaminophen Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Barbiturates Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Cardiacs II Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Cardiacs I Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Anticonvulsants Control2007-12-05
UTAK LABORATORIES, INC.
UTAK LABORATORIES TOXICOLOGY CONTROL1991-04-12
UTAK LABORATORIES, INC.
TRACE ELEMENTS SERUM TOXICOLOGY CONTROL1988-10-06
UTAK LABORATORIES, INC.
SERUM VANCOMYCIN TOXICOLOGY CONTROL1986-11-13
UTAK LABORATORIES, INC.
BENZODIAZEPINES TOXICOLOGY CONTROL1986-11-13
UTAK LABORATORIES, INC.
SERUM CLONAZEPAM TOXICOLOGY CONTROL1986-11-05
UTAK LABORATORIES, INC.
UTAK-STABBS TOXICOLOGY CONTROL1986-08-04
UTAK LABORATORIES, INC.
TRICYCLIC ANTIDEPRESSANTS1983-07-28
UTAK LABORATORIES, INC.
FLURAZEPAM TOXICOLOGY CONTROL1983-07-26
UTAK LABORATORIES, INC.
CAFFINE TOXICOLOGY CONTROL1983-07-26
UTAK LABORATORIES, INC.
MAPROTILINE1983-07-26
UTAK LABORATORIES, INC.
AMOXAPINE 8-HYDRO-XYAMOXAPINE1983-07-26
UTAK LABORATORIES, INC.
TRICYCLIC ANTIDEPRESSNATS VI1983-07-19
UTAK LABORATORIES, INC.
DISOPYRAMIDE N-DESALKYLDISOPYRAMIDE1983-07-06
UTAK LABORATORIES, INC.
PENTOBARBITAL TOXICOLOGY CONTROL1983-07-06
UTAK LABORATORIES, INC.
TOXICOLOGY CONTROL1981-02-04
UTAK LABORATORIES, INC.
TRICYCLIC ANTIDEPRESSANTS I TX CONTROL1980-05-02
UTAK LABORATORIES, INC.
TRICYCLIC ANTIDEPRESSANT II TX CONTROL1980-04-29
UTAK LABORATORIES, INC.
HYPNOTICS PLUS SALICYLATE TX CONTROL1980-04-29
UTAK LABORATORIES, INC.
HYPNOTICS PLUS ACETAMINOPHEN TX CONTROL1980-04-29
UTAK LABORATORIES, INC.
BARBITURATES TOXICOLOGY CONTROL1980-04-29
UTAK LABORATORIES, INC.
CARDIACS II TOXICOLOGY CONTROL1980-04-29
UTAK LABORATORIES, INC.
CARDIACS I TOXICOLOGY CONTROL1980-04-29
UTAK LABORATORIES, INC.
ANTICONVULSANTS TOXICOLOGY CONTROL1980-04-29

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